Drug major Pfizer Inc (PFE) and German partner BioNTech SE (BNTX) Thursday announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization of a booster dose of its COVID-19 Vaccine to include 16 and 17-year olds.
A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use in individuals 18 years of age and older, as well as for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.
The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series.
“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“From the beginning, we aimed to provide strong, safe protection to as many people as possible in an effort to end this pandemic. While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended.”
“The booster vaccination increases the level of immunity and dramatically improves protection against COVID-19 in all age groups studied so far,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In the current situation, it is important to offer everyone a booster, particularly against the background of the newly-emerging variants such as Omicron.”
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